Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans

NCT02051426 | Completed Results

• 1 other identifier: 112-06
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The efficacy of compounds having agonistic activity at the glycine site associated with the N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy human organism are not known. The investigators studied neuropsychiatric and neurochemical effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects using a randomized, controlled crossover challenge design including a baseline assessment day and two treatment administration days (DSR and placebo in randomized order). Thirty-five subjects aged 23-29 years participated in the study and received a 2.1g orally administered DSR dose. The main outcome measures were the changes in scores of mood-related Visual Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey Auditory Verbal Learning Test (RAVLT).

Conditions

Healthy

Keywords

neuropsychiatric effects

Outcome Measures

Primary Outcomes (3)

• Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours

  The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 \[no anxiety\] to 10 \[maximum anxiety\] ).

  Baseline, 2 hours post intervention

• Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours

  The "d-prime score" is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity.

  Baseline, 2 hours post intervention

• Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours

  RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.

  Baseline, 2 hours post intervention

Study Arms (2)

D-serine

EXPERIMENTAL

single P.O. administration of D-serine (2.1g)

Other: D-serine

Placebo

PLACEBO COMPARATOR

single P.O. administration of corn starch

Other: Placebo

Interventions

D-serine OTHER

single P.O. administration of D-serine (2.1g)

Also known as: DSR

D-serine

Placebo OTHER

single P.O. administration of Placebo

Also known as: corn starch

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers

You may not qualify if:

• history of psychiatric, medical, neurological illness or substance abuse

Sponsors & Collaborators

• Herzog Hospital: lead

Related Publications (1)

• Levin R, Dor-Abarbanel AE, Edelman S, Durrant AR, Hashimoto K, Javitt DC, Heresco-Levy U. Behavioral and cognitive effects of the N-methyl-D-aspartate receptor co-agonist D-serine in healthy humans: initial findings. J Psychiatr Res. 2015 Feb;61:188-95. doi: 10.1016/j.jpsychires.2014.12.007. Epub 2014 Dec 24.

  PMID: 25554623 DERIVED

MeSH Terms

Interventions

Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Uriel Heresco-Levy, M.D.
• Organization: Herzog Hospital

urielh@ekmd.huji.ac.il

+972-2-5316906

Study Officials

• Uriel Heresco-Levy, M.D.

  Herzog Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: April 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 19, 2014
• Results First Posted: November 19, 2014

Record last verified: 2014-11